Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).
The aim of this substudy of MARCH is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study MARCH. The investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
76
NRTI + PI
PI + maraviroc
NRTI + maraviroc
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina
Hospital General de Agudos J M Ramos Mejia
Buenos Aires, Buenos Aires F.D., Argentina
Fundación IDEAA
Buenos Aires, Buenos Aires F.D., Argentina
St. Vincent's Hospital
Sydney, New South Wales, Australia
Brisbane Sexual Health and HIV Service
Brisbane, Queensland, Australia
Southern Alberta Clinic
Calgary, Alberta, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Clinic Opus/Lori
Montreal, Quebec, Canada
Klinikum der Universitat Zu Koln
Cologne, Germany
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie, MX-Ambulanz
Düsseldorf, Germany
...and 5 more locations
changes in proteinuria and albuminuria between baseline and week 96
To compare the change in protein and albumin excretion as measured by the urine PCR and ACR through the kidneys between the randomised and standard of care (control) arm of MARCH.
Time frame: 96 weeks
changes in renal tubular function between baseline and week 96
To evaluate the following aspects of renal function at baseline and changes within and between study groups: * Tubular function defined as proximal tubular function; ascending thick loop of Henle; distal tubular function; volume and renal potassium handling; * Non-tubular function i.e. eGFR; Urine albumin:creatinine ratio; * Determine factors associated with renal dysfunction within the cohort e.g. demographics, HIV related, HIV-treatment related, co-morbidities, concomitant medication (such as ACE inhibitors and ARB; PI/r co-administered with TDF); TDF use;
Time frame: 96 weeks
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